Counterfeiting and blending of high-end products with cheaper material has become a major liability problem for major brand names. The International Chamber of Commerce (ICC) reported that in 2008, counterfeited goods resulted in a loss of $650 billion in revenues and 2.5 million jobs. The ICC projected that the loss in revenues will exceed $1.7 trillion in 2015, which is equivalent to 2% of the world economy. In addition to the revenue losses, certain counterfeit products were linked directly to serious health and safety issues. The counterfeit goods have infiltrated most industries from textiles to microchips, and even pharmaceuticals.
Counterfeiting has become a serious problem, spreading throughout many different industries all around the world. It was estimated that about $600 billion worth of counterfeited goods enter the market on a yearly basis (Cattaui, 2012). Products including pharmaceuticals, toys, entertainment products, clothing, fashion accessories, money, electronics, and any other products of value have imitation counterfeits in the market for consumers. The problem with counterfeits is that they not only hurt the name of the original and the economy, but because these products are not coming from reliable sources, their quality and efficacy could be compromised. Counterfeiting often has minimal consequences on those distributing the fake goods, compared to the deadly consequences that could result from the malfunctioning of products with counterfeit components. In 2011, VisionTech of Clearwater, Fla. was one of the few companies actually charged for the sale of counterfeit chips, after thousands of these fake chips had been sold to all sectors of the electronics industry.
Counterfeiting pharmaceuticals has also become a giant industry within the United States. These fake drugs can be extremely dangerous as there is no precision or consistency required to sell them. By using real or similar drugs to pass the initial testing, these counterfeiters can later sell products with a variety of different ingredients, without the knowledge of the consumer. A trend of global increase in medicine purchased online has made it easier to sell counterfeit pharmaceuticals. These counterfeits have made up 70% of the drug supply in nations such as China and India, leading to many more deaths all over the world, as these nations supply drugs to many other countries (See Chakraborty, FoxBusiness, June 2012). In April of 2012, a drug called Avastin, a cancer drug, was imitated. “ . . . 120 phony vials were purchased in Turkey under the name Alzutan and shipped through Britain by U.K.-based middlemen in a strikingly similar shipment pattern as the fakes that first hit U.S. doctors' offices in February.” These counterfeit drugs are sold for high profits, with low penalties, making this process attractive for criminals. This has become a multi-billion dollar industry, with an estimate of reaching $100 billion dollars within the next decade (Chakraborty). This could pose some serious health risks for consumers, who will gravitate towards the cheaper products, which are unknowingly counterfeits, making them susceptible to these fakes.
Another industry that has been invaded with counterfeit products is the electronics industry. Other than the well-known counterfeiting of standard music players and phones, products such as microchips have also been counterfeited. This is a major predicament because a customer of these products is the United States Department of Defense (DoD). Counterfeit microchips from the far east have made their way into the Navy and the Pentagon's weapons systems (Kelley, Business Insider, Military & Defense). These counterfeit manufacturers first develop products that function like the original to pass the initial testing, but then manufacture inferior, cheaper products, while still selling them as the original. Once they enter the weapons stream, the counterfeits are incredibly difficult to detect, and due to their unreliability, higher product failure has resulted, leaving a large vulnerability in national defense. Not only could these products fail, but access to faulty microchips within United States' weapons systems from unauthorized sources, could allow access into American communications without detection (Kelley).
Cases of counterfeit microchips mostly go unreported, with no consequences to those in the supplier chain, as companies are reticent to associate themselves with the fakes and risk the fallout from acknowledging that their systems may be compromised. In the case of the THAAD (Terminal High-Altitude Area Defense) system, a U.S. military program, they disclosed that their system was compromised in a way to protect themselves from future counterfeit parts and to raise awareness to the issue plaguing these systems. This system was developed to take down missiles in flight, requiring a high degree of precision, which could be jeopardized by a malfunction in any one of its chips. These counterfeit microchips, mainly purchased from Far Eastern sources, are frequently commercial-grade products that are not capable of withstanding the environment that military equipment must endure, meaning that equipment could cease to function abruptly, leading to disastrous consequences.
A new mandate, Section 818, with the National Defense Authorization Act for Fiscal Year 2012 has been created in support of measures to protect against counterfeiting. This mandate requires companies selling parts or products to the United States government to have anti-counterfeiting measures in place. These include inspecting and authenticating their products before they are sold. The mandate also holds suppliers responsible for the counterfeit products they supply, including the costs and legal ramifications of any damage that occurs due to the faulty products. Until this mandate was added to the National Defense Authorization Act, there had been no legal consequences for providing counterfeit products to consumers and no enforced monitoring or detection system required.
The risk involved with counterfeiting has forced many companies to act on their own to find ways to protect their products and set up anti-counterfeiting methods. One of the approaches used is to add a fluorophore to the products, to be able to visually detect which products are legitimate. A fluorophore is a chemical compound that fluoresces or re-emits light of a longer wavelength upon being excited with light. This occurs as a molecule within the fluorophore is excited causing the molecule to emit photons and fluoresce. The fluorophore can serve as a dye or a marker for these products, which can be applied during the early stages of production.
This method, although effective at first, no longer protects products as counterfeiters have copied the products along with the fluorophore. Counterfeiters were able to extract the fluorophore from the product, duplicate it, and add to their counterfeit products, making the product fluoresce under UV light just as the real product would. This has created a need for an anti-counterfeiting method by which products can be forensically authenticated which is secure and cannot be duplicated by the counterfeiters themselves. One method that the US Military is now looking into is the use of DNA to mark authentic products. DNA, with specific sequences, is incorporated into these products through the means of ink or other materials. This can then be detected under a UV light, with the way the material fluoresces. The specific DNA sequences are virtually impossible to duplicate, making counterfeiting impossible. This DNA would be impossible to remove as it would be embedded throughout the entire material.
Nucleic Acids as Security Markers
Despite being composed of relatively simple nucleotide building blocks, nucleic acids are capable of encoding a vast array of information: for instance, the human genome encodes all the information necessary for the synthesis and assembly of all the components of the human body from the neural networks of the brain to the intricate structures of the skeleton, tissues and organs. Nucleic acids include deoxyribonucleic acid (DNA) and the more labile ribonucleic (RNA). Nucleic acid sequences can be unique and complex and utilization of these particular characteristics in solving several common coding problems, such as authenticating and tracking products and detecting counterfeit products, has recently attracted great interest.
Many product manufacturers utilize apparent qualities and definitive designs identifiable as “trade dress” to uniquely identify their high quality and high value products and thereby earn the trust of their customers. Others also add labels for anti-counterfeit purposes. Traditional anti-counterfeiting labels are generally formed from materials having particularly targeted physical or chemical characteristics, for example, magnetic strips on checkbooks, laser holographs on credit cards, fluorescent ink on stock certificates, and heat-sensitive inks on confidential documents. Anti-counterfeiting labels have also been made by adding specific antigens to objects that need to be identified, the antigens can then be detected with an antibody specific for the antigen. However, antigens and antibodies are proteins with characteristically poor stability under many environmental conditions of temperature and humidity, and are prone to denaturation or even degradation and consequently lose activity and can easily be destroyed, thereby reducing the accuracy and reliability of identification.
Thus, nucleic acids, such as, for example, deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) which encode essential hereditary information have been looked to as an improved alternative to commonly used anti-counterfeiting labels and markers. DNA and RNA are polymers consisting of a chain of nucleotides, referred to as “oligonucleotides” consisting of relatively short chains of up to say, twenty to fifty bases in length, or “polynucleotides” for longer chains. These oligonucleotide or polynucleotide chains consist of a number of nucleotides linked together in sequence like beads on a string. Each nucleotide consists of a ribose sugar-phosphate linked to one of only four kinds of nitrogenous bases: adenine (often represented in abbreviated form as “A”), guanine (represented as “G”), cytosine (represented as “C”) and thymine (represented as “T”) in the case of DNA; and adenine (A), guanine (G), cytosine (C) and uracil (U) in the case of RNA. The oligonucleotides or polynucleotides share the same sugar-phosphate backbone. The 3′-hydroxyl group of the ribose sugar of one nucleotide is covalently bonded to the 5′-phosphate group of its neighboring nucleotide to form a chain structure with each of the planar nitrogenous bases protruding from the chain not unlike the teeth of a comb.
The bases A, T, G and C in one oligonucleotides or polynucleotides chain are each capable of specific-pairing with another base a different chain to form a double stranded structure, or with the same chain to form a double stranded loop or hairpin structure: Adenine specifically bonds with thymine through two hydrogen bonds in DNA (or with uracil in RNA) and cytosine specifically bonds with guanine through three hydrogen bonds. That is, T will bond to A and G to C bringing two nucleotide chains together to form a double strand, or two parts of a single nucleotide chain together to form a double stranded region with each strand of the duplex connected by a loop.
An additional advantage of nucleic acids for use as markers or taggants is that with the appropriate proper protection these molecules can be preserved for long periods of time. Evidence from preserved specimens in glaciers, ice sheets, tar pits and bogs and marshes shows that DNA is resilient to degradation over thousands, and in some cases millions of years. Such evidence has been used to deduce information concerning the ancestry and origins of ancient peoples as well as of plants and animals. Protected marker DNA can also be stabilized in polymers for coating of high value articles or objects of interest so as to survive long periods of time and can then used for identification, authentication and tracking purposes. This ability to persist over long periods of time coupled with very sensitive methods to detect low numbers of molecules for instance by amplification using the polymerase chain reaction (PCR), makes nucleic acids, and DNA in particular, an attractive candidate for use as a marker. Moreover, nucleic acids offer an almost unlimited coding capacity since the number of possible unique sequences increases fourfold with every additional base of the sequence of the oligonucleotide or polynucleotide.
There is a need in the art for a system permitting efficient, stable and detectable marking of an article, particularly an article of value with DNA taggants for the purposes of identification, authentication, tracking and validation. There is a need to protect brand names, to easily and rapidly detect counterfeited products and provide forensic evidence to assist in the prosecution of counterfeiters.